<p>，/PRNewswire/ -- LifeVac LLC 今天宣布，美国食品药品监督管理局（FDA）已根据 21 CFR 874.5400 授予 LifeVac De Novo 分类，正式确立该设备类型为 “吸引式防窒息设备，作为第二线治疗。”</p>
<p>继续阅读</p>
<p><img src="https://imageproxy.pbkrs.com/https://www.prnewswire.com/news-releases/null?x-oss-process=image/auto-orient,1/interlace,1/resize,w_1440,h_1440/quality,q_95/format,jpg" alt="" original-src="https://imageproxy.pbkrs.com/https://www.prnewswire.com/news-releases/null"/></p>
<p>LifeVac</p>
<p>根据该命令，LifeVac 被归类为 II 类医疗设备。FDA 将此设备类型定义为旨在通过吸引作用解决完全气道阻塞的窒息受害者，并在基本生命支持（BLS）窒息协议未成功后，作为紧急情况下的第二线治疗。</p>
<p>批准的适应症声明，LifeVac 是一种非电动、非侵入性、仅限单次使用的气道清除设备，旨在用于成人和儿童窒息受害者（至少 1 岁），可由普通人或医疗专业人员（18 岁或以上）在家庭、养老院、餐馆和学校等场所使用。</p>
<p>FDA 确定 II 类分类，加上一般和特殊控制，为该设备的预期使用提供了合理的安全性和有效性保证。</p>
<p>“正如命令中所述，LifeVac 旨在在 BLS 窒息协议失败后使用，” LifeVac 创始人兼首席执行官 Arthur Lih 说。“这一分类为作为第二线治疗的吸引式防窒息设备创建了明确的监管框架。”</p>
<p>根据该命令，LifeVac 可以立即按照 De Novo 请求中描述的方式进行市场营销，前提是遵循 FDA 概述的一般和特殊控制。</p>
<p><strong>关于 LifeVac LLC：</strong> LifeVac 是一家以其同名的救生气道清除设备而闻名的公司。成立于 2012 年，总部位于纽约州 Nesconset。它已在 MHRA 注册，并在澳大利亚 ARTG 注册。</p>
<p><strong>媒体联系人：</strong> Laura Bonelli</p>
<p>516-659-4122</p>
<p>[email protected]</p>
<p>来源 LifeVac</p>
<p><img src="https://imageproxy.pbkrs.com/https://rt.prnewswire.com/rt.gif/query-RGF0ZUlkPTIwMjYwMzA2Jk5ld3NJdGVtSWQ9UEgwMjg5MSZUcmFuc21pc3Npb25fSWQ9MjAyNjAzMDYwODQ4UFJfTkVXU19VU1BSX19fX19QSDAyODkx?x-oss-process=image/auto-orient,1/interlace,1/resize,w_1440,h_1440/quality,q_95/format,jpg" alt="" original-src="https://imageproxy.pbkrs.com/https://rt.prnewswire.com/rt.gif/query-RGF0ZUlkPTIwMjYwMzA2Jk5ld3NJdGVtSWQ9UEgwMjg5MSZUcmFuc21pc3Npb25fSWQ9MjAyNjAzMDYwODQ4UFJfTkVXU19VU1BSX19fX19QSDAyODkx"/></p>

<p>LifeVac LLC 的反窒息装置已获得 FDA 的 De Novo 分类，成为首个也是唯一一个获得 FDA 授权的吸引反窒息装置。LifeVac 被归类为 II 类医疗器械，旨在在基本生命支持协议失败后用于紧急情况。该装置适用于一岁以上的成人和儿童，可以由普通人或医疗专业人员在各种环境中使用。此分类确保了该装置在其预期用途上的安全性和有效性</p>

<p>, /PRNewswire/ -- LifeVac LLC announced today that the U.S. Food and Drug Administration (FDA) has granted De Novo classification for LifeVac under 21 CFR 874.5400, formally establishing the device type &#34;suction anti-choking device as a second-line treatment.&#34;</p>
<div class="lb-trans"><p>，/PRNewswire/ -- LifeVac LLC 今天宣布，美国食品药品监督管理局（FDA）已根据 21 CFR 874.5400 授予 LifeVac De Novo 分类，正式确立该设备类型为 “吸引式防窒息设备，作为第二线治疗。”</p>
</div><p>Continue Reading</p>
<div class="lb-trans"><p>继续阅读</p>
</div><p><img src="https://imageproxy.pbkrs.com/https://www.prnewswire.com/news-releases/null" alt="" original-src="https://www.prnewswire.com/news-releases/null"/></p>
<p>LifeVac</p>
<div class="lb-trans"><p>LifeVac</p>
</div><p>Under the order, LifeVac is classified as a Class II medical device. The FDA defines this device type as one intended to be used, by application of suction, to resolve choking in victims experiencing complete airway obstruction, and to be used as a second-line treatment in an emergency situation after unsuccessful use of a basic life support (BLS) choking protocol.</p>
<div class="lb-trans"><p>根据该命令，LifeVac 被归类为 II 类医疗设备。FDA 将此设备类型定义为旨在通过吸引作用解决完全气道阻塞的窒息受害者，并在基本生命支持（BLS）窒息协议未成功后，作为紧急情况下的第二线治疗。</p>
</div><p>The cleared indications state that LifeVac is a non-powered, non-invasive, single-use-only airway clearance device intended for adult and pediatric choking victims (at least 1 year of age), and may be administered by a lay person or medical professional (18 years or older) in settings including homes, nursing homes, restaurants, and schools.</p>
<div class="lb-trans"><p>批准的适应症声明，LifeVac 是一种非电动、非侵入性、仅限单次使用的气道清除设备，旨在用于成人和儿童窒息受害者（至少 1 岁），可由普通人或医疗专业人员（18 岁或以上）在家庭、养老院、餐馆和学校等场所使用。</p>
</div><p>FDA determined that Class II classification, together with general and special controls, provides reasonable assurance of the safety and effectiveness of the device for its intended use.</p>
<div class="lb-trans"><p>FDA 确定 II 类分类，加上一般和特殊控制，为该设备的预期使用提供了合理的安全性和有效性保证。</p>
</div><p>&#34;As stated in the order, LifeVac is intended to be used after a BLS choking protocol fails,&#34; said Arthur Lih, Founder and CEO of LifeVac. &#34;This classification creates a clear regulatory framework for suction anti-choking devices used as a second-line treatment.&#34;</p>
<div class="lb-trans"><p>“正如命令中所述，LifeVac 旨在在 BLS 窒息协议失败后使用，” LifeVac 创始人兼首席执行官 Arthur Lih 说。“这一分类为作为第二线治疗的吸引式防窒息设备创建了明确的监管框架。”</p>
</div><p>As a result of the order, LifeVac may immediately market the device as described in the De Novo request, subject to the general and special controls outlined by FDA.</p>
<div class="lb-trans"><p>根据该命令，LifeVac 可以立即按照 De Novo 请求中描述的方式进行市场营销，前提是遵循 FDA 概述的一般和特殊控制。</p>
</div><p><strong>About LifeVac LLC:</strong> LifeVac is a company known for its lifesaving airway clearance device of the same name. Founded in 2012, it is based out of Nesconset, New York. It is registered with MHRA, and Australia ARTG.</p>
<div class="lb-trans"><p><strong>关于 LifeVac LLC：</strong> LifeVac 是一家以其同名的救生气道清除设备而闻名的公司。成立于 2012 年，总部位于纽约州 Nesconset。它已在 MHRA 注册，并在澳大利亚 ARTG 注册。</p>
</div><p><strong>Media Contact:</strong> Laura Bonelli</p>
<div class="lb-trans"><p><strong>媒体联系人：</strong> Laura Bonelli</p>
</div><p>516-659-4122</p>
<div class="lb-trans"><p>516-659-4122</p>
</div><p>[email protected]</p>
<div class="lb-trans"><p>[email protected]</p>
</div><p>SOURCE LifeVac</p>
<div class="lb-trans"><p>来源 LifeVac</p>
</div><p><img src="https://imageproxy.pbkrs.com/https://rt.prnewswire.com/rt.gif/query-RGF0ZUlkPTIwMjYwMzA2Jk5ld3NJdGVtSWQ9UEgwMjg5MSZUcmFuc21pc3Npb25fSWQ9MjAyNjAzMDYwODQ4UFJfTkVXU19VU1BSX19fX19QSDAyODkx" alt="" original-src="https://rt.prnewswire.com/rt.gif?NewsItemId=PH02891&amp;Transmission_Id=202603060848PR_NEWS_USPR_____PH02891&amp;DateId=20260306"/></p>

LifeVac 成为首个也是唯一获得 FDA 授权的防窒息设备